Purpose

In November of 2013, the United States Food and Drug Administration (FDA) passed the Drug Supply Chain Security Act (DSCSA). The DSCSA was created to strengthen the security of the drug distribution supply chain by adding controls such as a national pharmaceutical track and trace system and establishing national standards for licensing of prescription drug wholesale distributors and third-party logistics providers (3PLs).

Impact

DSCSA requires trading partners, including manufacturers, repackagers, wholesale distributors and dispensers to provide transaction information to subsequent purchasers for certain prescription drugs. The DSCSA defines these prescription drugs as finished drugs intended for human use.

Transaction information may be provided in a paper or electronic format and must be maintained for a minimum of six years. The act also requires that trading partners only use 3PLs that have completed all required documentation necessary to be considered authorized by the FDA.

Implementation

The DSCSA is being implemented in stages over the course of 10 years. One of the first stages of this process was the November of 2014 release of a guidance document: The DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished and Prescription Drugs: How to Exchange Product Tracing Information. The guidance explains how information should be exchanged between parties within the pharmaceutical supply chain and set January of 2015 as the date when trading partners must begin to provide their subsequent purchasers with product tracing information.

The FDA followed with guidance, DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers, in December of 2014. This guidance provides details on how wholesalers and 3PLs should report DSCSA information to the FDA on an annual basis.

The DSCSA requires 3PLs to have a valid license in any state to or from which they distribute drugs or be licensed by the FDA itself. Currently only two states, California and Florida, have licensing programs for 3PLs, and any state license is superseded by the new FDA authorization for 3PLs.

Reporting

The FDA requires that all 3PLs submit an initial report by March 31 of 2015 to include the following for each of its locations: name of company as it appears on license and all trade names used to do business; address of facility; license information for each state and state license number. Additionally, the FDA requests that the following also be submitted with the initial report: name of contact person to interact with FDA; email address; phone number; unique facility identifier (Dunn & Bradstreet D-U-N-S number); expiration date for license and significant disciplinary actions by any State or Federal agency that occurred in the 12 months preceding the initial report and state where occurred,  along with date of final action, disciplinary action, description of violation and documents associated with disciplinary action.

These reports will be due by 31 March of each year moving forward. The FDA will use them to create a public database of information on authorized 3PLs in the U.S.

In addition to these reporting requirements the FDA plans to define further regulations for 3PLs to acquire and maintain authorization by November of 2015. Marken, the industry’s only Clinical Logistics Organization, has completed all required and requested documentation with the FDA and is in compliance with the DSCSA. Once final regulations are released by the FDA, Marken will make any necessary adjustments required.

Compliance

Marken’s team of regulatory experts has been closely following the DSCSA since its inception. “We have monitored the implementation process to be sure that we comply with all FDA requirements and requests,” says Marken’s Senior Manager of Regulatory Compliance, Reynaldo Roman. “We understand the importance of the DSCSA and how relevant it is to our clients, the industry and its stakeholders, so we are careful to understand its policies and comply with them,” adds Roman.

Marken’s knowledgeable regulatory team continually examines developments in all industry regulations.

We can provide guidance on DSCSA compliance and submission of transaction information. As the DSCSA implementation plan continues to roll out and develop over the next few years, Marken will remain informed and prepared to comply with additions and changes to regulations as they are released.

Marken has the expertise and FDA compliance necessary to provide third party logistics services throughout the United States. Email us at info@marken.com for more information on how we can support your drug distribution.